New Year's Miracle Weight Loss Drug or Not?

The FDA removes another product off the shelves.

So the time of year has come to put your New Year’s resolutions into action, but buyer beware! There are many tempting products on the market claiming to help you achieve your goal in a quick, sustainable manner. However, beware of any claims that are too good to be true.

Do you remember back in the 80s and mid-90s all the hype about a miracle weight loss combination pill Fen-Phen, also known as fenfluramine or dexfenfluramine and phentermine?

This combination of pharmaceuticals was being prescribed by doctors who believed the drug curbed appetite and helped patients shed pounds. 

However on Sept. 15, 1997, the FDA announced the withdrawal of Fen-Phen from the market, according to FDA.gov

The Food and Drug Administration has asked the manufacturers to voluntarily withdraw both treatments for obesity from the market. 

The action was based on new findings from doctors who have evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicated that approximately 30 percent of patients who were evaluated, had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results.

“These findings called for prompt action,” said Michael A. Friedman, M.D., the Lead Deputy Commissioner of the FDA. “The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine, present an unacceptable risk at this time to patients who take them.”

So, bring us back to present day. As of Dec. 6, the FDA issued another withdrawal of a weight loss miracle drug and this time it is for a homeopathic weight loss aid. The weight loss aid is human chorionic gonadotropin or HCG. The use of HCG was never intended for weight loss. The use of HCG or human chorionic gonadotropin was only approved for the use of infertility, fertility and as a tumor marker.

Although this drug has been believed to be a new weight loss miracle, it was first introduced to the weight loss market in the 1950s by Dr. Albert T.W. Simeon. The claims made were never proven true even after extensive clinical trials, so the usage of HCG for weight loss became less popular in the 1970s.

The reintroduction of HCG was due in part by a book written by Kevin Trudeau “The Weight Loss Cure 'They' Don’t Want You to Know About” and presented in the format of infomercials. This book was just a long line of misrepresentations; ironically Kevin Trudeau had a history of misrepresenting himself and was charged so by the FTC.  

In 1998 Kevin Trudeau was charged with making false claims. In doing so he moved to selling his systems, such as his weight loss system through his books. Although Trudeau was not the only reason for HCG to be reintroduced, the help of his late night infomercials played a large role.

“These products are marketed with incredible claims and people think that if they're losing weight, HCG must be working,” says Elizabeth Miller, acting director of FDA’s Division of Non-Prescription Drugs and Health Fraud. “But the data simply does not support this; any loss is from severe calorie restriction. Not from the HCG," as stated on the FDA’s consumer page on HCG.

The HCG Diet is making remarkable claims about losing large amounts of weight in a short period of time. The claim is that your appetite is being suppressed, so you should consume only 500 calories a day in combination with HCG and you will lose plenty of weight. However, as explained by one of the FDA’s nutritionists, Shirley Blakely, “Living on 500 calories a day is not only unhealthy—it’s hazardous, according to FDA experts. Consumers on such restrictive diets are at increased risk for side effects that include gallstone formation, an imbalance of the electrolytes that keep the body’s muscles and nerves functioning properly, and an irregular heartbeat.”

They can be dangerous, she says, and potentially fatal.

Even the American Society of Bariatric Physicians has stated concerns in a position paper “On Use of HCG for the Treatment of Obesity":

Although there were a few early studies in agreement with Simeons recommendations, a number of subsequent studies produced evidence that the HCG in the Simeons method was ineffectual and that the weight loss was entirely due to the diet. A meta-analysis review in 1995 of prior studies concluded that there is no scientific evidence that HCG is effective in the treatment of obesity. The meta-analysis found insufficient evidence supporting the claims that HCG is effective in altering fat-distribution, hunger reduction or in inducing a feeling of well-being. The authors stated ' …the use of HCG should be regarded as an inappropriate therapy for weight reduction.' In the authors' opinion, 'Pharmacists and physicians should be alert on the use of HCG for Simeons therapy.'

According to a press release issued Dec. 6, the FDA is advising consumers to steer clear of these "homeopathic" HCG weight-loss products.

"They are sold in the form of oral drops, pellets and sprays and can be found online and in some retail stores," the press release states. "FDA and the Federal Trade Commission (FTC) have issued seven letters to companies warning them that they are selling illegal homeopathic HCG weight-loss drugs that have not been approved by FDA, and that make unsupported claims.

"FDA advises consumers who have purchased homeopathic HCG for weight loss to stop using it, throw it out, and stop following the dieting instructions. Harmful effects should be reported online to FDA’s MedWatch program or by phone at 800-FDA-1088 (800-332-1088) and to the consumer’s health care professional."

As history would tell us about Fen-Phen, although the significant effects of HCG have not been found at this time, the FDA has chosen to remove these products due to their overwhelming surge in popularity again. So, if you are currently hoping that your New Year’s resolution can be solved by a quick fix, think again and remember that if it sounds too good to be true, you are probably right.

When it comes to health and wellness, a balanced approach of healthy eating, purposeful exercise and a healthy lifestyle are the true keys to reaching any resolution. The lasting effects of balance are truly what make your quality of life better than the potential lasting effects of a hazardous “miracle” pill.

ui September 24, 2012 at 09:33 AM
View your weight loss chart often for inspiration or to determine how much weight you have to lose in order to reach your goals. Thanks for sharing. Regards, http://www.creativebioscience.com/


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